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Irbesartan in the Treatment of Hypertensive Patients With Metabolic Syndrome

This study has been completed.
Sponsor:
Collaborator:
Sanofi
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00110422
First received: May 9, 2005
Last updated: April 7, 2011
Last verified: June 2010
  Purpose

The purpose of this clinical research study is to learn if irbesartan is superior to hydrochlorothiazide relative to effects on insulin sensitivity and glucose metabolism in hypertensive patients with metabolic syndrome.


Condition Intervention Phase
Metabolic Syndrome
Hypertension
Drug: Irbesartan
Drug: Hydrochlorothiazide
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Irbesartan in the Treatment of Hypertensive Patients With Metabolic Syndrome

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Change from baseline in insulin resistance(MatsudaIndex)Week16

Secondary Outcome Measures:
  • Change from baseline in insulin resist-QuickiIndex Week16;Change from baseline in triglyc.,BP,hs-CRP,albumin/creatinine ratio Week16;Changes from baseline-Matsuda,QuickiIndex,BP,triglyc.,hs-CRP&albumin/creatinine ratio Week28

Estimated Enrollment: 400
Study Start Date: November 2005
Study Completion Date: February 2007
Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A1 Drug: Irbesartan
Tablets, Oral, 150 mg. titrated to 300 mg, once daily, 28 weeks.
Other Name: Avapro
Active Comparator: B1 Drug: Hydrochlorothiazide
Tablets, Oral, 12.5 mg. titrated to 25 mg, once daily, 28 weeks.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects must be willing and able to provide written informed consent. Subjects must read, sign, and receive a copy of the informed consent prior to any study procedures, including withdrawal of any antihypertensive medication.
  • Males and females >= 18 years of age.
  • Uncontrolled hypertension defined as an average systolic blood pressure >= 140 mmHg and/or an average diastolic blood pressure >= 90 mmHg. This applies to both people not taking any blood pressure medications and people taking just one blood pressure medication.
  • Presenting at least 2 of the following:

    • Obesity;
    • High triglycerides;
    • Low HDL cholesterol;
    • Elevated fasting glucose.

Exclusion Criteria:

  • Women of child bearing potential who are not using adequate birth control.
  • Women who are pregnant or breastfeeding
  • Diabetics
  • Systolic blood pressure >= 180 mmHg.
  • Diastolic blood pressure >= 110 mmHg.
  • Stroke within past 12 months.
  • Myocardial infarction and heart revascularization procedure or acute angina within past 6 months.
  • Moderate to severe heart failure.
  • Significant kidney or liver disease.
  • Cancer in past 5 years.
  • Drug or alcohol abuse.
  • Gout
  • Lupus
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00110422

Locations
France
Local Institution
Angers, France
Local Institution
Nantes, France
Local Institution
Tierce, France
Germany
Local Institution
Hannover, Germany
Local Institution
Muenchen, Germany
Local Institution
Ornbau, Germany
Local Institution
Rotenburg An De Fluda, Germany
Local Institution
Tuebingen, Germany
Local Institution
Villingen-Schwenningen, Germany
Italy
Local Institution
Ancona, Italy
Local Institution
Chieti Scalo, Italy
Local Institution
Pisa, Italy
Local Institution
Ravenna, Italy
Local Institution
Sassari, Italy
Norway
Local Institution
Oslo, Norway
Local Institution
Snaroya, Norway
Russian Federation
Local Institution
Moscow, Russian Federation
Local Institution
Saratov, Russian Federation
Local Institution
St. Petersburg, Russian Federation
Local Institution
Yaroslavl, Russian Federation
Spain
Local Institution
A Coruna, Spain
Local Institution
Barcelona, Spain
Local Institution
Granada, Spain
Local Institution
Sevilla, Spain
Local Institution
Zaragoza, Spain
Sponsors and Collaborators
Bristol-Myers Squibb
Sanofi
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00110422     History of Changes
Other Study ID Numbers: CV131-186
Study First Received: May 9, 2005
Last Updated: April 7, 2011
Health Authority: United States: Food and Drug Administration
France: Ministry of Health

Keywords provided by Bristol-Myers Squibb:
Metabolic Syndrome

Additional relevant MeSH terms:
Hypertension
Metabolic Syndrome X
Syndrome
Cardiovascular Diseases
Disease
Glucose Metabolism Disorders
Hyperinsulinism
Insulin Resistance
Metabolic Diseases
Pathologic Processes
Vascular Diseases
Hydrochlorothiazide
Irbesartan
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Antihypertensive Agents
Cardiovascular Agents
Diuretics
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Natriuretic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014